BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK HAKIM PROGRAMMABLE VALVE

    MDR report key: 6435718 · Received March 27, 2017

    Report

    Report Number
    1226348-2017-10191
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    June 27, 2016
    Product Code
    JXG
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI UNAVAILABLE. IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPARISON OF ELEVATED INTRACRANIAL PRESSURE PULSE AMPLITUDE AND DISPROPORTIONATELY ENLARGED SUBARACHNOID SPACE (DESH) FOR PREDICTION OF SURGICAL RESULTS IN SUSPECTED IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS¿, PUBLISHED ACTA NEUROCHIR (2016) 158:2207¿2213 DOI 10.1007/S00701-016-2858-5, IT WAS REPORTED THAT 1 UNKNOWN PATIENT HAD COMPLICATIONS AFTER USE OF AN UNKNOWN ICP SENSOR AND 1 UNKNOWN PATIENT HAD A SHUNT RELATED INFECTION POST IMPLANTATION OF AN UNKNOWN HAKIM PROGRAMMABLE VALVE. PER THE ARTICLE: ¿BACKGROUND TO COMPARE THE PROGNOSTIC VALUE OF PULSE AMPLITUDE ON INTRACRANIAL PRESSURE (ICP) MONITORING AND DISPROPORTIONATELY ENLARGED SUBARACHNOID SPACE HYDROCEPHALUS (DESH) ON MAGNETIC RESONANCE IMAGING (MRI) FOR PREDICTING SURGICAL BENEFIT AFTER SHUNT PLACEMENT IN IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS (INPH)¿ CONCLUSIONS BOTH POSITIVE DESH FINDINGS AND HIGH ICP PULSE AMPLITUDE SUPPORT THE DIAGNOSIS OF INPH AND PROVIDE ADDITIONAL DIAGNOSTIC VALUE FOR PREDICTING SHUNT-RESPONSIVE PATIENTS; HOWEVER, HIGH ICP AMPLITUDE WAS MORE ACCURATE THAN POSITIVE DESH FINDINGS, ALTHOUGH IT IS AN INVASIVE TEST.¿ THERE WAS NO FURTHER INFORMATION REGARDING EITHER REPORTED COMPLICATION EVENT. THERE WAS NO TREATMENT REPORTED FOR THOSE 2 EVENTS. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218649 UNK HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention